DDS Exam 1 Questions With 100% Correct Answers

DDS Exam 1 Questions With 100% Correct Answers define indication specific use for a drug -its labeled use [FDA approved] 2 other names for psuedopolymorphs hydrates or solvates 2 requirements for FDA approval to market a drug product -show safety and efficacy -shop process control and validation (will they work the same every time) 2 main stages of drug development process are preclinical and clinical (study done in humans) 4 steps of drug discovery 1. "target" identification and validation 2. "hit" identification and screening (molecule that interacts with targets) 3. "lead" identification and optimization (prototype chemical that has desired biological or pharmacological activity) 4. "candidate" preclinical then clinical drug development (lead that is most suited for further investigation) explain pharmacodynamics investigates biochemical and physiological effects of drugs, including their mechanism of action explain toxicology investigates potential for adverse effects -short term (for single dose or short-term multiple dose effects) -long term (chronic studies) What does ADME stand for in pharmacokinetics? absorption, distribution, metabolism, excretion What must be filed with FDA before human testing Investigational New Drug Application -comprehensive application detailing all aspects of pre-clinical studies and plan for clinical studies Purpose of 30-day waiting period -ensure research subjects are not exposed to unreasonable risks -IND is reviewed by experts Possible outcomes of 30 day review -safe to proceed (trial will begin) -clinical hold (proposed trial is not safe to proceed, FDA will explain what must be done to reverse the hold) -partial clinical hold (may proceed under restrictions described in letter of sponsor) Purpose of Phase 1-3 drug trials 1: safety and dosage 2: effectiveness and short term safety 3: effectiveness and long term safety Patient Type of Phase 1-3 drug trials 1: healthy volunteers (metabolism and excretion studies) 2: patients suffering from indicated condition 3: patients suffering from indicated condition # of volunteers of Phase 1-3 drug trials 1: 20-100 2: 100-500 3: Length of Phase 1-3 drug trials 1: 1.5 years 2: 2 years 3: 3.5 years % of drugs successfully completing Phase 1-3 drug trials 1: 67% 2: 45% 3: 5-10% What is the NDA -FDA drug application that must be approved -integrates all data with 1000+ pages and can take up to 10 months to sort through Quality standards that must be in line with during inspection portion of drug approval process -comply with application quality standards -comply with quality standards in FDA's Current Good Manufacturing Practice Standards 2 possible results of FDA's decision in drug development -approval letter -complete response letter --outlines deficiencies and may